MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AA6314
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9304422.
Event or Problem Description
According to the available information, the patient gets a new catheter in and two days later the balloon breaks.The patient ends up in the emergency to get a new catheter because he cannot void his urine.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9304422.Burst issue of silicone balloon is known but according to the available information we cannot conclude on a specific root cause in this case.Quality database was checked and revealed a corrective and preventive action: capa-000152."balloon issues on folysil and silicone prostatic catheters" was opened and monthly monitored.No corrective action will be implemented as our trend is not increasing.A similar case study was perfomed based on folysil silicone, same defect "burst" over last four year, 210 similar cases were found.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information, the patient gets a new catheter in and two days later the balloon breaks.The patient ends up in the emergency to get a new catheter because he cannot void his urine.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 20569179
• Report Number: 9610711-2024-00300
• Device Sequence Number: 12627604
• Product Code: EZL
• UDI-Device Identifier: 03600040128640
• UDI-Public: 3600040128640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K233411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6314
• Device Lot Number: 9304422_AA63141002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown